<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
50909-2002-1
</NDCCode>
<PackageDescription>
1 BAG in 1 DRUM (50909-2002-1) / 12500 TABLET, COATED in 1 BAG
</PackageDescription>
<NDC11Code>
50909-2002-01
</NDC11Code>
<ProductNDC>
50909-2002
</ProductNDC>
<ProductTypeName>
DRUG FOR FURTHER PROCESSING
</ProductTypeName>
<ProprietaryName/>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Zongertinib Film-coated Tablets, 60 Mg
</NonProprietaryName>
<DosageFormName>
TABLET, COATED
</DosageFormName>
<RouteName/>
<StartMarketingDate>
20250816
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
DRUG FOR FURTHER PROCESSING
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
HOVIONE FARMACIENCIA SA
</LabelerName>
<SubstanceName>
ZONGERTINIB
</SubstanceName>
<StrengthNumber>
60
</StrengthNumber>
<StrengthUnit>
mg/1
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Unfinished
</Status>
<LastUpdate>
2025-08-18
</LastUpdate>
<PackageNdcExcludeFlag/>
<ProductNdcExcludeFlag/>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
16-AUG-25
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage/>
</NDC>